Medix Biotech, Inc.
Medical device manufacturer in San Carlos, CA.
39510(k) clearances
0PMA approvals
0recalls
Device types
- JHI Visual, Pregnancy Hcg, Prescription Use 9
- CGJ Radioimmunoassay, Follicle-Stimulating… 4
- GTZ Antisera, All Groups, Streptococcus Spp. 3
- CEP Radioimmunoassay, Luteinizing Hormone 3
- CFT Radioimmunoassay, Prolactin (Lactogen) 3
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 3
- DGC Ige, Antigen, Antiserum, Control 2
- DBF Ferritin, Antigen, Antiserum, Control 2
- CFL Radioimmunoassay, Human Growth Hormone 2
- KLI Enzyme Immunoassay, Non-Radiolabeled, Total… 2
- MSJ Apolipoproteins 1
- DHA System, Test, Human Chorionic Gonadotropin 1
- JMG Radioimmunoassay (Two-Site Solid Phase)… 1
- DHB System, Test, Radioallergosorbent (Rast)… 1
- JJX Single (Specified) Analyte Controls… 1
- CDP Radioimmunoassay, Total Triiodothyronine 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K952873 | Medix Biotech Strep a Antigen Detection Test (Modification)GTZ · Traditional | 09/08/1995SE |
| K952319 | Contrast & Rapid HCG Urine/Serum TSTJHI · Traditional | 06/20/1995SE |
| K932482 | Medix Biotech Bestest Strep a Cat. No. BSF1010GTZ · Traditional | 07/18/1994SE |
| K932758 | Medix Biotech Bestest Hcg-Urine Test KitJHI · Traditional | 09/28/1993SE |
| K925436 | Medix Biotech Total T3 Enzyme Immunoassay Test KitCDP · Traditional | 12/28/1992SE |
| K924259 | Medix Biotech Bestest(Tm) Hcg-Urine, Cat# B1H0100JHI · Traditional | 11/25/1992SE |
| K922047 | Ige Enzyme Immunoassay Test Kit Cat.No. KIF4064DGC · Traditional | 08/05/1992SE |
| K921700 | TSH Enzyme Immunoassay Test Kit Cat. No. KIF4093JLW · Traditional | 06/29/1992SE |
| K920712 | Medix Biotech Throxine Enzyme Immunoassay Test KitKLI · Traditional | 03/27/1992SE |
| K920345 | Prolactin Enzyme Immunoassay Test Kit (Modified)CFT · Traditional | 03/18/1992SE |
| K920299 | Medix Biotech Hghenzyme Immunoassay Test KitCFL · Traditional | 03/04/1992SE |
| K920504 | Medix Biotech LH Enzyme Immunoassay Test KitCEP · Traditional | 03/02/1992SE |
| K920253 | Medix Biotech HCG Enzyme Immunoassay Test KitJHI · Traditional | 02/14/1992SE |
| K920046 | Modified Ferritin Enzyme Imunoassay Test KitDBF · Traditional | 01/28/1992SE |
| K914756 | Ultrasensitive TSH (U-Tsh) Enzyme Immuno Test KitJLW · Traditional | 01/15/1992SE |
| K915208 | FSH Enzyme Immunassay Test Kit NO:KIF4057CGJ · Traditional | 12/18/1991SE |
| K914696 | Medix Biotech Total HCG Enzy Immun Test KT DIF4011JHI · Traditional | 11/13/1991SE |
| K901345 | Modified FSH Enzyme Immunoassay Test Kit NO.MB1050CGJ · Traditional | 05/10/1990SE |
| K897144 | THYROXIN(T4) Enzyme Immunoassay Test KitKLI · Traditional | 03/15/1990SE |
| K896587 | Modified HCG Enzyme Immunoassay Test KitJHI · Traditional | 02/16/1990SE |
| K896642 | Modified LH Enzyme Immunoassay Test KitCEP · Traditional | 01/30/1990SE |
| K896640 | Modified FSH Enzyme Immunoassay Test KitCGJ · Traditional | 01/02/1990SE |
| K896643 | Human Growth Hormone Enzyme Immunoassay MB-1015CFL · Traditional | 12/29/1989SE |
| K896641 | Modified Prolactin Enzyme Immunoassay Test KitCFT · Traditional | 12/27/1989SE |
| K896585 | Modified Ferritin Enzyme Immunoassay Test KitDBF · Traditional | 12/04/1989SE |
| K894400 | Micro-Plate Reader, MDX-1JJX · Traditional | 10/23/1989SE |
| K881596 | FSH Enzyme Immunoassay Test Kit No. MB-1057CGJ · Traditional | 05/27/1988SE |
| K874281 | Medix Biotech Ige Visual Screening Test KitDHB · Traditional | 12/18/1987SE |
| K874406 | Ige Enzyme Immunoassay Test Kit No. MB-1064DGC · Traditional | 11/25/1987SE |
| K873730 | Medix Biotech Ferritin Enzyme Immunoassay Test KitJMG · Traditional | 11/04/1987SE |
| K874061 | TSH Enzyme Immunoassay Test Kit No. MB-1093JLW · Traditional | 11/03/1987SE |
| K873872 | HCG Enzyme Immunoassay Test Kit Catalog #MB-1013DHA · Traditional | 10/28/1987SE |
| K873355 | Medix Biotech Prolactin Enzyme Immuno. Test KitCFT · Traditional | 10/09/1987SE |
| K873668 | Medix Biotech LH Enzyme Immunoassay Test KitCEP · Traditional | 10/07/1987SE |
| K872346 | Sure-Strep a Test Kit Catalog No. MB-1083GTZ · Traditional | 09/30/1987SE |
| K872794 | Medix Biotech Apolipoprotein A-I Test KitMSJ · Traditional | 09/23/1987SE |
| K860490 | Medix Visual HCG - M HCG Enzyme ImmunoassayJHI · Traditional | 03/05/1986SE |
| K850949 | Medix Visual Urine HCG (7/7) TestJHI · Traditional | 04/12/1985SE |
| K850987 | Medix Visual Serumo HCG L10/10 Test HCG Enzyme ImmJHI · Traditional | 04/08/1985SE |